FDA UDI In Commercial Distribution 🇺🇸 United States

SteriTec EO Sterilization Indicator Tape

DI: 00814434020165 · Model: CI 124/1 · STERITEC PRODUCT MFG. CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SteriTec EO Sterilization Indicator Tape
Primary DI
00814434020165
Version / Model
CI 124/1
Catalog Number
CI 124/1
Company Name
STERITEC PRODUCT MFG. CO., INC.
Labeler DUNS
622223196
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6ca74d3e-8403-44df-9d1e-37635b5b07c7

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JOJ Indicator, Physical/Chemical Sterilization Process

GMDN Terms

Code Name
44427 Sterilization packaging tape

Identifiers

Type ID
Package 10814434020162
Primary 00814434020165

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
10 – 60 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
10 – 38 Degrees Celsius